eMonarcHER: A Randomized Double Blind Placebo-Controlled Phase 3 Study of Abemaciclib plus Standard Adjuvant Endocrine Therapy in Participants with High-Risk Node-Positive HR+ HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    High-risk, Node-positive, Hr+, Her2+ Early Breast Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Have high risk disease, defined by one of the following: For participants treated with neoadjuvant therapy: Pathologically detected axillary nodal disease in the surgical specimen For participants not treated with neoadjuvant therapy: Axillary node positive disease meeting one of the following: -Pathological tumor involvement in =4 ipsilateral axillary lymph nodes -Pathological tumor involvement in 1-3 ipsilateral axillary lymph node(s) and at least 1 of the following *Histological Grade 2 or Grade 3 *Primary invasive tumor size =5 cm determined pathologically 2) The participant has confirmed HR+, HER2-positive (HER2+) in initial diagnostic tissue, early invasive breast cancer without evidence of disease recurrence or distant metastases. 3) The participant must have undergone definitive surgery of the primary breast tumor(s). 4) Participants have completed up to one year of standard HER2-targeted therapy without evidence of disease recurrence.

You may not be eligible for this study if the following are true:

  • 1) Have breast cancer with any of the following features: Disease recurrence or distant metastatic disease (including contralateral axillary lymph nodes) Lymph node-negative status. 2) Pathological complete response from any prior systemic treatments for early breast cancer Inflammatory breast cancer. 3) Participants with a history of previous breast cancer, with the exception of ipsilateral DCIS treated by locoregional therapy alone =5 years ago.


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